UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of sample collection method for determination of Fusobacterium nucleatum in oral cavity
Acronym	Investigation of sample collection method for determination of Fusobacterium nucleatum in oral cavity
Scientific Title	Investigation of sample collection method for determination of Fusobacterium nucleatum in oral cavity
Scientific Title:Acronym	Investigation of sample collection method for determination of Fusobacterium nucleatum in oral cavity
Region	Japan

Condition
Condition	Not applicable (Healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate a sample collection method for quantitative evaluation of the abundance of Fusobacterium nucleatum in the oral cavity of healthy subjects.
Basic objectives2	Others
Basic objectives -Others	Research
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Quantification of the number of Fusobacterium nucleatum and Fusobacterium spp. in oral specimens. Quantitative evaluation focusing on a specific strain.
Key secondary outcomes	Detection and quantification of pathogenic genes of Fusobacterium nucleatum. 16S rRNA gene-based or shotgun metagenome analysis.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria	1. Subjects who have participated in other clinical trials requiring oral health care within 3 months prior to obtaining consent or are currently participating in other clinical trials. 2. Subjects with dentures (including implants) or undergoing orthodontic treatment. 3. Subjects who consumed antibiotics during last 3 months. 4. Subjects with serious or progressive diseases or conditions. 5. Subjects who are currently visiting a dentist or receiving treatment within 3 months prior to obtaining consent (any treatment related to teeth or gums). 6. Subjects who have been determined ineligible by principal investigator or study administrator. 7. Subjects who routinely consume medicines, health foods, supplements, food for specified health uses, or functional foods that affect the oral environment. 8. Subjects with a current or previous food or drug allergy. 9. Smoker 10. Subjects who have excessive drinking habits. 11. Subjects who are currently pregnant or breastfeeding, or who wish to become pregnant during the study period.
Target sample size	6

Research contact person
Name of lead principal investigator	1st name Mitsuharu Middle name Last name Matsumoto
Organization	Kyodo Milk Industry Co. Ltd.
Division name	Research Laboratories
Zip code	190-0182
Address	20-1 Hirai, Hinode-machi, Nishitama-gun, Tokyo
TEL	042-597-5911
Email	m-matumoto@meito.co.jp

Public contact
Name of contact person	1st name Naomi Middle name Last name Yuzawa
Organization	IMEQRD Co., Ltd
Division name	Sales department
Zip code	104-0061
Address	6-2-1 Ginza Chuo-ku Tokyo Japan
TEL	03-6704-5968
Homepage URL
Email	n-yuzawa@imeqrd.co.jp

Sponsor
Institute	Kyodo Milk Industry Co. Ltd.
Institute
Department

Funding Source
Organization	Kyodo Milk Industry Co. Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Iryouhoujinsyadan Hakusuikai, Suda Clinic institutional review board
Address	2-8-14, Takadanobaba, Shinjyuku, Tokyo, Japan
Tel	03-6704-5968
Email	n-yuzawa@imeqrd.co.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	協同乳業株式会社研究所

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2021 Year 02 Month 18 Day
Date of IRB	2021 Year 02 Month 24 Day
Anticipated trial start date	2021 Year 03 Month 08 Day
Last follow-up date	2021 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study Design: Research Subject Recruitment: Subjects who meet the selection criteria and do not meet the exclusion criteria will be selected from healthy adult volunteers. Main items to be measured: The number of Fusobacterium nucleatum in oral specimens.

Management information
Registered date	2021 Year 03 Month 02 Day
Last modified on	2021 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049592